| FDA Regulations of Medical Technologies
Sponsored with the Massachusetts Medical Device Industry Council (Mass MEDIC) and Health and Biomedical Law Concentration
Please Note: This course has already
been held.
Date: Friday, November 12, 2004
Location: Suffolk University Law School, 120 Tremont St., Boston, MA
Time: 09:00 AM - 04:30 PM
Faculty
Schedule/Agenda
Registration Information
Unable to attend but are interested in the course materials?
Purchase Here! |
|
Course Materials for Download
Feigal.htm
hamilton.htm
Feigal2.htm
The medical device industry is one of Massachusetts’ most important business sectors. For calendar year 2002 the medical device industry in Massachusetts employed over 20,000 people who earned in excess of $1.2B in wages. These workers developed and manufactured medical devices that their employer firms sold for in excess of $5B. For these reasons, the Massachusetts’ medical device industry holds a prominent position within the US medical device sector.
The vigor of the medical device industry in Massachusetts can be seen by the large array of companies and the technologies they have developed. They range in size from start-ups to public companies. A common challenge faced by each of these companies, whether large or small, is obtaining FDA approval to market their products. On the one hand, the share price of a public company’s stock can be positively or negatively affected by the FDA approval process. On the other hand, early stage companies must demonstrate compliance with the FDA requirements in order to attract needed capital.
Attend and Learn:
- What technologies are regulated as "devices"
- The regulatory approval paths for differing types of devices
- FDA inspection and enforcement authority
| |
Barry Brown
|
| |
Co-Chair, Health & Biomedical Law Concentration
Suffolk University law School, Boston, MA |
| |
|
| |
Professor Renée M. Landers
|
| |
Director, Health & Biomedical Concentration, Suffolk University Law School, Boston, MA |
| |
|
| |
Mark C. Butts
|
| |
Boston Equity Advisors, LLC, Canton, MA |
| |
|
| |
Mary S. Consalvi
|
| |
Adjunct Professor, Suffolk University Law School |
| |
|
| |
Gail T. Costello
|
| |
New England District Office
U.S. Food and Drug Administration, Stoneham, MA |
| |
|
| |
David W. Feigal, Jr.
|
| |
NDA Partners, LLC, North Potomac, MD
Former Director of FDA Medical Product Areas |
| |
|
| |
John A. Hamilton
|
| |
Perkins, Smith & Cohen, LLP, Boston, MA |
| |
|
| |
Mark A. Heller
|
| |
Senior Partner, Chair, FDA Department
Wilmer, Cutler, Pickering, Hale and Dorr, LLP, Washington, D.C. |
| |
|
| |
Robert B. Nicholas
|
| |
Chair, FDA Practice Group, McDermott, Will & Emery, LLP, Washington D.C. |
| |
|
| |
John C. Serio
|
| |
Brown Rudnick Berlack & Israels, LLP, Boston, MA |
| |
|
| S C H E D U L E / A G E N D A |
| 9:00 |
Welcome and Introductions |
Professor Barry Brown, Co-Chair,Health & Biomedical Law
& Attorney Mark Butts, Program Chair
|
| 9:10 |
History of Regulation of Medical Technologies and FDA Structure |
| Attorney Mary Consalvi
|
| 9:40 |
Definition of a “Medical Device” §321(h) |
| “Intended Use”, Combination Devices, Software, Absorbable Devices, and Genetic Discoveries Attorney Mark A. Heller, Professor Barry Brown & Dr. David Feigal
|
| 10:45 |
Medical Device Classification and New Device Approval System |
| Approval System - Class I/II/III, “Safe and Effective,” Adequate Instructions for Use, §510(k) and “Substantial Equivalence,” Well Controlled Clinical Studies, Prescription (“Restricted”) Devices and OTC Attorney Robert Nicholas, Attorney Mark Heller & Dr. David Feigal
|
| 12:30 |
~Luncheon Address~ |
An Inside Look at the FDA Approval ProcessDr. David W. Feigal, Jr., is experienced in all three of the FDA’s medical product areas: medical devices, biologics and pharmaceuticals. He served as head of the HIV Division in the Center for Drug Evaluation and Research, the Director of the Division of Anti-Infective Drug Products and Director of the Office of Drug Evaluation IV, medical deputy director of the Center for Biologics Evaluation and Research and director of the Center for Device and Radiological Health. He began his distinguished career in academia teaching at the University of California. Dr Feigal is a medical doctor with a master’s degree in public health.
|
| 2:00 |
Prohibited Acts |
| Jurisdiction, Misbranding, Adulteration, State Issues and Advertising/Promotional Issues Attorney Robert Nicholas & Attorney John Serio
|
| 2:45 |
Other Issues |
| Regulation of Physician Prescribing Habits and “Off Label” Use, FDA Rulemaking Process and Challenges to Rules, FDA Inspection and Enforcement Director Gail Costello, Attorney John Hamilton & Professor Renée Landers
|
| Date: |
|
Friday, November 12, 2004 |
| Tuition: |
|
Tuition is $249; $199 for attorneys admitted to the Bar after 2001. Course book and refreshments included in the tuition charge. A limited number of partial scholarships are available. Please submit a written request via fax 617-305-3099.
|
| Walk-Ins: |
|
Space is limited. Registrations at the door are welcome, but please register in advance to reserve a seat and your written course materials or call to confirm space availability.
|
| Refunds: |
|
Written requests for cancellations received via fax or email 24 hours prior to the program will be granted a refund, minus a $15 charge. If you cannot attend, you can send a substitute, otherwise you will receive the written course materials.
|
| Location: |
|
Suffolk University Law School, 120 Tremont St., Boston, MA
|
| Credit: |
|
Approved for CLE Credit in NY, RI, NH, VT & ME.
|
Special
Needs: |
|
If you have special needs addressed by the Americans with Disabilities Act, please notify us as soon as possible.
|
Directions to the Law School.
|
Unable to attend but are interested in the course materials?
Purchase Here! |
|
|
Library 
